510(k) K112637

NETKONNECT REMOTE NETWORK EXTENSION by Nihon Kohden — Product Code MHX

K112637 is an FDA 510(k) premarket notification submitted by Nihon Kohden for the device "NETKONNECT REMOTE NETWORK EXTENSION". The FDA issued a decision of Substantially Equivalent on December 9, 2011. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Nihon Kohden has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2011
Date Received
September 9, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type